Bausch Health gets tentative FDA approval for BRYHALI Lotion

Bryhali is a steroid treatment for the chronic condition that causes dry, red skin lesions covered with silvery scales.

New Delhi: Bausch Health Cos Inc formerly known as Valeant Pharmaceuticals has recently received tentative U.S. approval to market its plaque psoriasis lotion, Bryhali.

U.S. Food and Drug Administration (FDA) has provided tentative approval of the New Drug Application for BRYHALI (halobetasol propionate) Lotion, 0.01%, for the topical treatment of plaque psoriasis in adult patients.

The final FDA approval for BRYHALI Lotion is pending the expiration of exclusivity for a related product, which is expected in early November 2018. The company plans to launch BRYHALI Lotion shortly thereafter, as scheduled, in November 2018.

BRYHALI Lotion is a new potent to superpotent corticosteroid that contains 0.01 per cent halobetasol propionate in a novel vehicle lotion. Its safety has been established in clinical trials with dosing for up to eight weeks with no increase in epidermal atrophy.

"Our customers and their patients can benefit from this new treatment option that is expected to provide the efficacy of a high-potency steroid with tolerability and longer duration of use," said Bill Humphries, president, Ortho Dermatologics. "Just as every psoriasis patient's journey is different, so too are their treatment needs, which is why psoriasis is a key therapeutic focus for our business. We look forward to adding BRYHALI Lotion to our growing psoriasis portfolio."

Topical steroids are the most frequently used treatment for psoriasis, but long-term use has been limited due to risks of adverse events such as epidermal atrophy. Other local adverse reactions from topical corticosteroids may include striae, telangiectasias, hypopigmentation and contact dermatitis, and some local adverse reactions may be irreversible. In clinical trials, BRYHALI Lotion was applied once daily for eight weeks and shown to be generally well-tolerated with no increase in epidermal atrophy.

"Topical steroids are a cornerstone of psoriasis treatment, but the efficacy of a high-potency steroid often comes with an increased risk of adverse events and a duration of use limited to two to four weeks," said Lawrence J. Green, M.D., associate clinical professor of Dermatology at George Washington University School of Medicine in Washington, D.C. "In clinical trials BRYHALI Lotion has demonstrated good local tolerability for up to eight weeks of treatment without sacrificing efficacy, making it an important new treatment option for psoriasis patients."